Thursday, February 02, 2023 9:06:08 PM
As described in its October 31 press release, the Company has Completed its review and documentation of Manufacturing and Packaging related Standard Operating Procedures.(SOPs) and is now awaiting external laboratory test resullts on Hemostyp samples produced under its new manufacturing arrangement..Upon receipt and review of the sample analysis, the company (expects) to submit its full PMA application within a few days. Update of 28 November,2022..
Dec.19, 2022---UHP continues to advance its, PMA Application with the FDA.. the company has received and reviewed external laboratory test results on the Hemostyp gauze product under its new manufacturing arrangement. The measured physical and chemical characteristics of the new product were shown to be effectively identicalto those of the Hemostyp gause product utilized in the company's human trial, (a Key step towards demonstrating a supply of equivalent product)
Recent UEEC News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/13/2023 10:05:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 09:10:10 PM
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